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Completed

NCT Number: NCT06814769

Hyaluronic Acid and Articular Pain

This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luca Gallelli

Catanzaro, CZ, 88100, Italy

About this study

This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.

The first efficacy end-point will be:

the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes between 18 and 65 years old, with a Body Mass Index < 29 kg/m2.
  • Patients with second- or third-degree of OA
  • Patients with VAS (Visual Analogue Scale) intensities higher than 5/10 who did not respond to systemic medication therapy.
  • Patients who can comprehend the study's objectives and (adhere to the orthopedist's instructions, return for follow-up, and complete the evaluation questionnaires).
  • Patients able to provide their written informed consent to participate to the study and to use their data anonymously for scientific purposes

Exclusion criteria

  • presence of active malignancy of any type or history of malignancy
  • Local or systemic infection.
  • Uncooperative patient or suffering from neurological disorders, therefore unable to follow the orthopedist's instructions or unable to provide informed consent for participation in the study or who have not provided written consent.
  • Any case not described in the inclusion criteria.

Treatment and study plan

Hyaluronic Acid

Device

intra-articular administration

Primary outcomes

  1. pain change

    Time frame: 12 months

    Numeric Pain Rating Scale: with a 0-10 points, where 0 is no pain and 10 is extreme pain

  2. mood anxiety : zung scale

    Time frame: 12 months

    20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety

Secondary outcomes

  1. mood depression: zung scale

    Time frame: 12 months

    20-items: score 20 to 49: no depression; 49-59 mild; 59-69 moderate; 70 - 80 severe anxiety

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

Hyaluronic Acid in the Management of Articular Pain

Acronym: HApain

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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